Rasmussen Keith G, Knapp Rebecca G, Biggs Melanie M, Smith Glenn E, Rummans Teresa A, Petrides Georgios, Husain Mustafa M, O'Connor M Kevin, Fink Max, Kellner Charles H
Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN 55905, USA.
J ECT. 2007 Dec;23(4):244-50. doi: 10.1097/yct.0b013e31814515d6.
The use of double-blind designs, normally the criterion standard of clinical trials, is impossible when comparing medication therapy to procedural therapies for depression. In the Consortium for Research in Electroconvulsive Therapy (CORE) trial, depressed patients recently remitted with electroconvulsive therapy (ECT) were randomly assigned to receive continuation therapy with either ECT or medications. The purpose of this article is to describe the design characteristics and challenges of the trial and of our method of dealing with the lack of double-blind outcome assessment.
The primary outcome measure was time to relapse of depression in the continuation phase. We developed a method to achieve partial blinding of depressive severity assessment. This consisted of videotaping the structured interviews, having the video tapes co-rated by personnel not involved in the patient's care, and a videotape-tracking maneuver so that the assessor of the videotapes could be blinded to phase and type of treatment.
We enrolled 624 patients into the initial treatment phase of the trial. Of these, 201 met criteria for randomization into the second, continuation phase. Our videotape-tracking maneuver to reduce bias in outcome assessment worked well during the trial.
The CORE study is the first multicenter, randomized controlled trial of continuation ECT in the relapse prevention of major depressive episodes. We successfully recruited a large number of severely depressed patients into a 6 month trial and used a method of reducing bias that might result from lack of blinding.
在比较抑郁症的药物治疗和程序治疗时，通常作为临床试验标准规范的双盲设计无法实施。在电休克治疗研究联盟（CORE）试验中，近期通过电休克治疗（ECT）缓解的抑郁症患者被随机分配接受ECT或药物的维持治疗。本文旨在描述该试验的设计特点、面临的挑战以及我们应对缺乏双盲结局评估的方法。
主要结局指标是维持治疗阶段抑郁症复发的时间。我们开发了一种方法来实现对抑郁严重程度评估的部分盲法。这包括对结构化访谈进行录像，让未参与患者护理的人员对录像带进行共同评分，以及一种录像带追踪策略，以使录像带评估者对治疗阶段和类型不知情。
我们将624名患者纳入试验的初始治疗阶段。其中，201名符合随机分组进入第二阶段即维持治疗阶段的标准。我们减少结局评估偏倚的录像带追踪策略在试验期间效果良好。
CORE研究是第一项关于维持ECT预防重度抑郁发作复发的多中心、随机对照试验。我们成功招募了大量重度抑郁症患者参加为期6个月的试验，并采用了一种方法来减少因缺乏盲法可能导致的偏倚。
